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01 1Fermion Oy
02 1Formosa Laboratories
03 1Hangzhou Longshine Bio-Tech
04 1Hetero Drugs
05 1MSN Laboratories
06 1Shandong Haohong Biotechnology Co.,ltd
07 1Sun-shine Chem
08 1Tecoland Corporation
09 1Teva API
10 1Viatris
01 3China
02 1Finland
03 2India
04 1Israel
05 1Taiwan
06 2U.S.A
01 2Active
02 8Blank
01 10Blank
01 10Blank
01 1WC-0349
02 9Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35585
Submission : 2021-01-30
Status : Active
Type : II
Date of Issue : 2022-09-02
Valid Till : 2025-05-05
Written Confirmation Number : WC-0349
Address of the Firm :
NDC Package Code : 54893-0109
Start Marketing Date : 2021-01-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34419
Submission : 2019-12-26
Status : Active
Type : II
NDC Package Code : 66499-0064
Start Marketing Date : 2018-08-24
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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